(301 days)
The O-arm® Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm® Imaging System is compatible with certain Image Guided Surgery Systems.
The O-arm® Imaging System is a portable x-ray system designed for 2D fluoroscopic and 3D imaging for high contrast objects and anatomic structures.
The O-arm® Imaging System is compatible with certain Image Guided Surgery Systems. The O-arm® Imaging System may be used with medical charged particle radiation therapy systems for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks.
The O-arm® Imaging System is a mobile x-ray system which provides 3D imaging as well as 2D fluoroscopic imaging. The system consists of two parts: the x-ray O-arm® Stand (comprising x-ray generator, flat dynamic x-ray detector, and the x-ray control user interface) and the mobile view station (comprising the image processors, a user interface for image and patient handling, and viewing monitor).
The provided document is a 510(k) summary for the Medtronic O-arm® Imaging System. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain a study that proves the device meets specific acceptance criteria.
The document states: "Based on design characteristics and imaging performance, the modified O-arm® Imaging System is substantially equivalent to the predicate Oarm® Imaging." This suggests that the device was deemed substantially equivalent to a predicate, rather than being subjected to a specific performance study with acceptance criteria.
Therefore, most of the information requested in your prompt cannot be extracted from this document, as it focuses on substantial equivalence rather than a detailed performance study against acceptance criteria.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document does not specify quantitative acceptance criteria or report device performance against such criteria. It relies on a qualitative comparison to a predicate device, stating "Same as predicate O-arm® with image quality improvement."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided. No test set or study data is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Cannot be provided. No ground truth establishment related to a specific study is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Cannot be provided. This document is for an imaging system (hardware), not an AI-assisted diagnostic device. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Cannot be provided. This document is for an imaging system (hardware), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot be provided. No specific ground truth for performance evaluation is mentioned.
8. The sample size for the training set:
- Cannot be provided. No training set is mentioned as this is an imaging system, not an AI algorithm.
9. How the ground truth for the training set was established:
- Cannot be provided. No training set is mentioned.
Summary based on the provided text:
The submission focuses on demonstrating substantial equivalence to existing predicate O-arm® Imaging Systems. The primary method of "proving" its acceptability is through this comparison, noting that the "modified O-arm® Imaging System is substantially equivalent to the predicate Oarm® Imaging" based on "design characteristics and imaging performance." There is no detailed performance study with specific acceptance criteria outlined in this document.
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JUN 17 2010
792564
Attachment E - 510(k) Summary
Date prepared June 10, 2010
510(k) Owner Medtronic Navigation, Inc. (Littleton)
Phone: 978-698-6045 Fax: 763-367-8304
Contact Seth Kuzdzal, RA/QA Manager
Trade name O-Arm Imaging System
Common name Mobile x-ray system
Classification Name: System, X-ray, mobile name Regulation: 21 CFR 892.1720 Product codes LINE OXD
- O-arm® Imaging System, which was cleared to market in 510(k)s Predicate device K050996 and K060344.
Device The O-arm® Imaging System is a mobile x-ray system which provides description 3D imaging as well as 2D fluoroscopic imaging.
The system consists of two parts: the x-ray O-arm® Stand (comprising x-ray generator, flat dynamic x-ray detector, and the x-ray control user interface) and the mobile view station (comprising the image processors, a user interface for image and patient handling, and viewing monitor).
Indications for The O-arm® Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a use physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm® Imaging System is compatible with certain Image Guided Surgery Systems.
P. I ನ
K092564 Medtronic Navigation O-arm Imaging System Medironic O-am Imaging System
page 30 of 31
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Comparison to the predicate
device
| ModifiedO-arm® | PredicateO-arm® | |
|---|---|---|
| Indications foruse | Mobile x-ray imagingdesigned for 2Dfluoroscopic and 3Dimaging and is intendedto be used where aphysician benefits from2D and 3D information ofanatomic structures andobjects with high x-rayattenuation such as bonyanatomy and metallicobjects.Compatible with certainImage Guided SurgerySystems. | The O-Arm™ ImagingSystem is designed for2D Fluoroscopic and 3Dimaging forintraoperativeapplications in surgicaltheaters, particularly fororthopedic applications.The O-Arm™ ImagingSystem is compatiblewith certain ImageGuided Surgery Systems. |
| Technology | Same as predicate O-arm®. | Mobile cone-beam x-raysystem with isocentricmotion options.O-arm® allows 3D imagereconstruction from 360°sweep of x-ray sourceand detector withinclosed gantry. |
| Imaging | Same as predicate O-arm® with image qualityimprovement. | 2D Fluoroscopy and 3DImaging. |
| Othercharacteristics | Same as predicate O-arm®. | Sterile accessories,wireless mouse, etc. |
Conclusion
.
Based on design characteristics and imaging performance, the modified O-arm® Imaging System is substantially equivalent to the predicate Oarm® Imaging.
K092584 Medtronic Navigation O-arm Imaging System Medtronic O-arm Imaging System
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three heads in profile, connected by a flowing ribbon-like shape. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Mr. Seth Kuzdzal RA/QA Manager Medtronic Navigation, Inc., Littleton 300 Foster Street LITTLETON MA 01460
NOV 1 4 2011
Re: K092564
Trade/Device Name: O-arm® Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system, mobile Regulatory Class: II Product Code: LHN and OXO Dated: June 10, 2010 Received: June 11, 2010
Dear Mr. Kuzdzal:
This letter corrects our substantially equivalent letter of June 17, 2010.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please Note: CDRH does not evaluate information related to contact liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must
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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely Yours,
Muthal POThm far
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K892564
.
ﻤﺎﺷ
Device Name: O-arm® Imaging System
Indications for Use
The O-arm® Imaging System is a portable x-ray system designed for 2D fluoroscopic and 3D imaging for high contrast objects and anatomic structures.
The O-arm® Imaging System is compatible with certain Image Guided Surgery Systems. The O-arm® Imaging System may be used with medical charged particle radiation therapy systems for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.